CASCO BAY MOLDING LTD.

Address:32 Smada Dr,Sanford,ME,04073,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cup, Menstrual (HHE) (6) Ring, Teething, Non-Fluid Filled (MEF) (4)

Premarket Exempt

Yes

Clear

Casco Cup - 00850004683408 Catalog Number :

Device Description : 100% medical-grade silicone

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Casco Cup - 00850004683415 Catalog Number :

Device Description : 100% medical-grade silicone

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Casco Cup - 00850004683422 Catalog Number :

Device Description : 100% medical-grade silicone

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Best, Periodt. - 00860004779001 Catalog Number :

Device Description : Best, Periodt. Menstrual Cup Size 1

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Best, Periodt. - 00860004779018 Catalog Number :

Device Description : Best Periodt. Menstrual Cup Size 2

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

BelaBud - 00860006321109 Catalog Number :

Device Description : Menstrual Cup

Device Class : 2

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : HHE

Prescription Use : No

Device Count : 1

Opulent Global - 00860006862701 Catalog Number :

Device Description : Single pink teether ring

Device Class : 1

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : MEF

Prescription Use : No

Device Count : 1

Opulent Global - 00860006862718 Catalog Number :

Device Description : Single blue teether

Device Class : 1

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : MEF

Prescription Use : No

Device Count : 1

Opulent Global - 00860006862725 Catalog Number :

Device Description : Single clear teether

Device Class : 1

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : MEF

Prescription Use : No

Device Count : 1

Opulent Global - 00860006862732 Catalog Number :

Device Description : 3 pack, blue, clear, pink

Device Class : 1

Duns Number: 604286695

Premarket Exempt : Yes

Product Code : MEF

Prescription Use : No

Device Count : 1

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